Prescription medication · Opioid Analgesic
hydromorphone
Also sold as Dilaudid. This medicine treats severe pain that requires an opioid pain medicine.
Data updated 2026-05-15
- 90,652
- FDA reportsOften reported
- 13
- InteractionsSeveral interactions
- 93% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
hydromorphone (Dilaudid) is a prescription Opioid Analgesic, more reported than most tracked drugs (90,652 FDA reports), whose generic costs a fraction of the brand (about 93% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
hydromorphone (Dilaudid) is a prescription Opioid Analgesic. This medicine treats severe pain that requires an opioid pain medicine.
Hydromorphone (Dilaudid) is a strong pain medicine. It is used to treat severe pain when other pain medicines do not work well enough.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
hydromorphone is currently listed as in shortage by the FDA. Affected manufacturer: Fresenius Kabi USA, LLC. Status: Unavailable.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$3.96/unit
Generic Price
$0.29/unit
Generic Savings
93%
Generic Available
Yes (11 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats severe pain that requires an opioid pain medicine.
Common side effects
Lightheadedness, Dizziness, Sleepiness
Key warnings
This medicine has a boxed warning.
The sections below are summarized in plain English from hydromorphone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Hydromorphone works by binding to receptors in the brain and spinal cord. This blocks pain signals from reaching the brain. This results in a decreased feeling of pain.
How to Take It
Take this medicine exactly as your doctor tells you. The oral solution is usually taken every 3 to 6 hours as needed for pain. Tablets are usually taken every 4 to 6 hours as needed for pain. Your doctor will start you on the lowest dose and adjust it as needed.
This is a plain-language summary of hydromorphone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Using this medicine for a long time during pregnancy can cause withdrawal symptoms in the baby after birth. Talk to your doctor if you are pregnant or plan to become pregnant. This medicine may not be recommended during labor.
This is a plain-language summary of hydromorphone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of hydromorphone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68° to 77°F) and protect from light. Keep this medicine secure and dispose of it properly.
Side Effects (from patient reports)
Based on 90,652 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for hydromorphone, by number of reports
- Addiction to the drug
Addiction to the drug
35,077 reports
- Taking too much of the drug
Taking too much of the drug
22,994 reports
- Pain
Pain
22,132 reports
- Emotional upset
Emotional upset
17,685 reports
- Death
Death
14,869 reports
- Withdrawal symptoms when stopping the drug
Withdrawal symptoms when stopping the drug
14,321 reports
- Harmful effects from different substances 10,057
Harmful effects from different substances
10,057 reports
- Feeling sick to your stomach 4,623
Feeling sick to your stomach
4,623 reports
- Tiredness 3,506
Tiredness
3,506 reports
- Throwing up 3,374
Throwing up
3,374 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for hydromorphone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where hydromorphone sits
hydromorphone has more FDA adverse-event reports than 84% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is hydromorphone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 90,652 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
90,652
Reports Mentioning Death
27,836
30.7% of reports — not proof of cause
Hospitalization Reports
16,698
Top Indication
Pain
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG DEPENDENCE | 35,077 |
| 2 | OVERDOSE | 22,994 |
| 3 | PAIN | 22,130 |
| 4 | EMOTIONAL DISTRESS | 17,685 |
| 5 | DEATH | 14,868 |
| 6 | DRUG WITHDRAWAL SYNDROME | 14,321 |
| 7 | TOXICITY TO VARIOUS AGENTS | 10,057 |
| 8 | NAUSEA | 4,622 |
| 10 | FATIGUE | 3,506 |
| 11 | VOMITING | 3,373 |
| 12 | ANXIETY | 3,352 |
| 14 | DRUG ABUSE | 3,103 |
| 15 | HEADACHE | 2,920 |
| 16 | DRUG HYPERSENSITIVITY | 2,840 |
| 17 | DRUG WITHDRAWAL SYNDROME NEONATAL | 2,770 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine has a boxed warning. It can cause serious and life-threatening risks. Taking too much can cause overdose and death. It can cause addiction, abuse, and misuse. It can also cause very slow or stopped breathing. Accidental intake, especially by a child, can cause a fatal overdose. Taking with alcohol or other depressants can cause coma and death. If you are pregnant, long-term use can cause withdrawal symptoms in the newborn.
Known Drug Interactions
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Both of these medications can increase the levels of a brain chemical called serotonin, which can lead to a serious reaction.
What to do: Tell your doctor immediately if you feel confused, agitated, or have a very fast heartbeat while taking these together.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Both drugs affect the serotonin system in the brain, and taking them together can cause serotonin levels to become dangerously high.
What to do: Your doctor should monitor you closely for signs of serotonin syndrome, such as confusion, sweating, or a fast heartbeat.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: This muscle relaxant and the pain medicine both impact serotonin levels, which can lead to a rare but serious reaction in the body.
What to do: Watch for symptoms like muscle stiffness or shivering and let your healthcare provider know immediately if they occur.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: These medications both change how serotonin works in your brain, which increases the risk of a severe and potentially dangerous reaction.
What to do: Use this combination with caution and report any unusual changes in your mood or physical coordination to your doctor.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Examples: Phenelzine, tranylcypromine, and linezolid.
Mechanism: This antibiotic acts as an MAO inhibitor, which can cause a dangerous buildup of serotonin when used with certain pain medications.
What to do: Your doctor may need to adjust your treatment or monitor you very carefully for signs of a serotonin reaction.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I stop taking this medicine suddenly?
Can I drink alcohol while taking this medicine?
What should I do if I feel like I'm becoming addicted to this medicine?
Can I drive while taking this medicine?
What should I do if I have trouble breathing?
Can I take other medicines with this?
How do I measure the oral solution?
What are the signs of an overdose?
Can this medicine cause constipation?
Is it safe to take this medicine if I have asthma?
What are the common side effects of hydromorphone?
Does hydromorphone interact with other medications?
What drug class is hydromorphone?
Is there a generic version of hydromorphone?
Is hydromorphone safe during pregnancy?
Is hydromorphone currently in shortage?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for hydromorphone
The FDA label for hydromorphone (sold under brand names such as Dilaudid) classifies it as a prescription-only medication in the Opioid Analgesic class. This medicine treats severe pain that requires an opioid pain medicine. Official labeling lists 11 commonly reported side effects, including Lightheadedness, Dizziness, Sleepiness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 90,652 voluntary reports. The database also lists 13 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.29 versus $3.96 for the brand - a 93% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 4, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages